MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC VENTILATORS VENTIPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 130003

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Alarm Not Visible (1022); Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that there was no audio or visual alarms.Battery tray was broken.Patient involvement unknown.

Event Description

Additional information received via email.Event occurred during testing.There was no patient involvement.

Manufacturer Narrative

D3, g1, and g2 email is: regulatory.Responses@icumed.Com.H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection noted the device was received in with a cracked housing underneath the battery compartment, damaged gas supply indicator with missing cover, damaged battery holder assembly, and a missing input fitting.Internal rattling was heard.The complaint was confirmed.The battery holder was damaged and the electronics would not function.The electronic audio and visual alarms would not present.Root cause was attributed to the battery door assembly.Problem source listed as "user interface".The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17239938
• MDR Text Key: 318218034
• Report Number: 3012307300-2023-06954
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130003
• Device Catalogue Number: 130003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1